Bayer and J&J Settle 25,000 Xarelto Claims
28.03.2019 -
At a cost of $775 million, Bayer and Johnson & Johnson have agreed to settle claims by patients against the top-selling anticoagulant Xarelto out of court.
The two drugmakers said they will split the payout evenly, but reserve the right to withdraw from the settlement if not enough plaintiffs agree to the terms.
While the lawsuits claim that the blood thinner caused severe and sometimes fatal bleeding episodes, J&J has told the court in previous cases that that the drug’s FDA-approved labeling has always warned of bleeding events, “a known risk associated with anticoagulation.”
Since the first case was heard more than five years ago, Bayer and J&J have won all. However, Bayer said it wants to resolve the more than 25,000 still pending, “to avoid the distraction and significant cost of continued litigation.”
“The safety profile of Xarelto remains positive and unchanged as confirmed time and again by regulatory agencies worldwide,” the German group said in a statement, adding that it continues to believe the claims are without merit and is making “no admission of liability.”
Johnson & Johnson also said it was not admitting liability. As one reason for settling out of court, the healthcare giant said news coverage of the trials and lawyers advertising for new plaintiffs have caused “confusion and concern.” In particular, some patients had stopped taking Xarelto after seeing the TV ads and suffered strokes and deaths.
Both drugmakers already have their hands full defending other products that in contrast to the Xarelto lawsuits carry a greater risk. Bayer faces more than 11,000 claims related to Monsanto’s glyphosate-containing Roundup herbicide, while J&J is confronted with 14,000.lawsuits over its talc-based baby powder.
Users of Roundup and Johnson’s baby powder respectively claim that the products caused their cancers.
Xarelto was launched in 2011. Over the eight-year period, sales have continued to increase. Bayer, which markets the drug in every market except the US, reported revenue of 3.63 billion ($4.11 billion) in 2018. J&J reported US sales of $2.48 billion. Bayer also receives license revenue on US sales.